Trial reportBMC pharmacology & toxicology2016
Pharmacokinetics of oral and intravenous melatonin in healthy volunteers.
Trial report in BMC pharmacology & toxicology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01923974 (The Analgesic Effects of Melatonin), which is not on this map. Cited by 91 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers
Who cites it
91 citing papers in PubMed, 174 citations in OpenAlex.
- Effects of bedtime melatonin treatment on blood pressure and arterial stiffness: a three-month, randomized, placebo-controlled crossover study in individuals with type 2 diabetes mellitus.Acta diabetologica · 2026Trial
- Trial
- Oral Melatonin in Critically Ill Patients With COVID-19: A Quasi-Experimental Pragmatic Trial.Journal of medical virology · 2026Trial
- Trial
- Melatonin Supplementation for Cancer-Related Fatigue in Patients With Early Stage Breast Cancer Receiving Radiotherapy: A Double-Blind Placebo-Controlled Trial.The oncologist · 2024Trial
- Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of Gastroesophageal Reflux Disease Symptoms: A Clinical Trial.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023Trial
- Melatonin supplementation reduces nighttime blood pressure but does not affect blood pressure reactivity in normotensive adults on a high-sodium diet.American journal of physiology. Regulatory, integrative and comparative physiology · 2023Trial
- Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers.Drugs in R&D · 2023Trial
- Dose assessment of melatonin in sepsis (DAMSEL2) study: Pharmacokinetics of two doses of oral melatonin in patients with sepsis.Journal of pineal research · 2022Trial
- Bioavailability of OniriaDrugs in R&D · 2022Trial
- Antioxidant Effect of Melatonin in Preterm Newborns.Oxidative medicine and cellular longevity · 2021Trial
- The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia.BMC women's health · 2020Trial
- The Effects of Melatonin on Elevated Liver Enzymes during Statin Treatment.BioMed research international · 2017Trial
- Pharmacokinetics of Intravenous Melatonin in Preschool-Aged Pediatric Surgical Patients.Paediatric anaesthesia · 2026Article
- Melatonin beyond chronobiology: integrating pharmacokinetics, dose-exposure forecasting, and clinical evidence.Molecular biology reports · 2026Review
- Review
- Review
- Dietary Protocols to Promote and Improve Restful Sleep: A Narrative Review.Nutrition reviews · 2026Review
- Responsiveness of ThymoDreamFrontiers in sleep · 2026Article
- Molecular mechanisms in diquat-induced organs injury：insights into cell signaling and potential therapeutic agents.Cell biology and toxicology · 2025Review
31 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim was to investigate the pharmacokinetics of oral and iv melatonin in healthy volunteers.
methodsThe study was performed as a cohort crossover study. The volunteers received either 10 mg oral melatonin or 10 mg intravenous melatonin on two separate study days. Blood samples were collected at different time points following oral administration and short iv infusion, respectively. Plasma melatonin concentrations were determined by RIA technique. Pharmacokinetic analyses were performed by "the method of residuals" and compartmental analysis. The pharmacokinetic variables: k a, t 1/2 absorption, t max, C max, t 1/2 elimination, AUC 0-∞, and bioavailability were determined for oral melatonin. C max, t 1/2 elimination, V d, CL and AUC 0-∞ were determined for intravenous melatonin.
resultsTwelve male volunteers completed the study. Baseline melatonin plasma levels did not differ significantly between the study days (P = 0.067). Mean (SD) t 1/2 absorption of oral melatonin was 6.0 (3.1) min. Mean t max was 40.8 (17.8) min with a median (IQR) C max of 3550.5 (2500.5-8057.5) pg ml(-1). Mean t 1/2 elimination was 53.7 (7.0) min. Median absolute bioavailability was 2.5 (1.7-4.7) %. Median C max after short iv infusion of melatonin was 389,875.0 (174,775.0-440,362.5) pg ml(-1). Mean t 1/2 elimination was 39.4 (3.6) min, mean V d 1.2 (0.6) l kg(-1) and mean CL 0.0218 (0.0102) l min(-1) kg(-1).
conclusionsThis cohort crossover study estimated pharmacokinetics of oral and iv melatonin, respectively in healthy volunteers. Bioavailability of oral melatonin was only 3 %.
trial registrationEudra-CT number: 2013-000205-23 (initial registration 27.03.2013). Clinicaltrials.gov Identifier: NCT01923974 (initial registration 08.08.2013).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.